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    The EU Clinical Trials Register currently displays   38197   clinical trials with a EudraCT protocol, of which   6274   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-006180-21
    Sponsor's Protocol Code Number:CA180-400
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-006180-21
    A.3Full title of the trial
    A PHASE IV, OPEN-LABEL, MULTICENTER STUDY OF
    DASATINIB IN CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA
    (CP-CML) PATIENTS WITH CHRONIC LOW-GRADE NONHEMATOLOGIC
    TOXICITY TO IMATINIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    dasatinib in chronic phase chronic mieloid leukemia patients with chronic toxicity to imatinib
    A.4.1Sponsor's protocol code numberCA180-400
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Start Up Department
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance, Avenue de Finlande, 8
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sprycel
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDASATINIB
    D.3.9.1CAS number 302962-49-8
    D.3.9.2Current sponsor codeBMS-354825
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CP-CML patients with non hematologic low toxicity grade to imatinib
    E.1.1.1Medical condition in easily understood language
    Patient affected by Chronic Phase Chronic Myeloid Leukemia under imatinib treatment who have mild toxic reactions not in the blood to imatinib
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the frequency of reduction in grade
    (Grade 2 to 1) or resolution of imatinib-related chronic Grade 1 or Grade 2
    non-hematologic AEs within 3 months after switch to dasatinib in patients with CP-CML.
    E.2.2Secondary objectives of the trial
    - Frequency of dasatinib-related AEs
    • Mean change in M.D. Anderson Symptom Inventory-Chronic Myeloid Leukemia
    (MDASI-CML) symptom severity and interference score from baseline to 3, 6, and
    12 months after switch to dasatinib
    • Mean change in EORTC-Quality of Life Questionnaire (EORTC-QLQ-C30) score
    from baseline to 6 and 12 months after switch to dasatinib
    • Proportion of patients with reduction in grade (Grade 2 to 1) or resolution of at least 1
    imatinib-related chronic Grade 1 or Grade 2 non-hematologic adverse event within
    3 months after switch to dasatinib, without an increase in grade of any
    imatinib-related, chronic, Grade 1 or 2, non-hematologic adverse event
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signed Informed
    - Subjects with CP-CML achieving an optimal response (either CHR by 3 months,
    PCyR by 6 months, or CCyR by 12 months) to imatinib ≤ 400 mg/day treatment
    - Currently experiencing at least one imatinib-related Grade 1 or 2 non-hematologic
    adverse event persisting for at least 2 months or recurring at least 3 times in the
    preceding 12 months, despite best supportive care
    Daily ECOG performance status = 0 – 2
    - Life expectancy >6 months
    - Adequate renal function defined as serum creatinine ≤ 3 times the institutional
    ULN
    - Adequate hepatic function defined as: total bilirubin ≤ 3.0 times the institutional
    ULN; alanine aminotransferase (ALT) and aspartate aminotransferase
    (AST) ≤ 5.0 times the institutional upper limit of normal (ULN)
    - Serum Na, K, Mg, and total serum Ca or ionized Ca levels must be greater than or
    equal to the institutional lower limit of normal. Subjects with low K, Mg levels,
    total serum Ca and/or ionized Ca must be repleted to allow for protocol entry.
    - Men and women, ages 18 or older
    - Women of childbearing potential (WOCBP) must use highly effective methods of
    birth control to minimize the risk of pregnancy. WOCBP must follow instructions
    for birth control for the entire duration of the study including a minimum of 1
    month (4 weeks) after dosing has been completed.
    Acceptable methods of highly effective birth control include:
    • Condom with spermicide
    • Diaphragm and spermicide
    • Cervical cap and spermicide
    The use of intrauterine devices, (IUDs) shall be at the discretion of the
    investigator.
    Women must have a negative serum or urine pregnancy test (minimum
    sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the
    start of investigational product.
    - Women must not be breastfeeding
    - Sexually active fertile men must use highly effective birth control if their partners
    are WOCBP. Men that are sexually active with WOCBP must follow instructions
    for birth control for the entire duration of the study and a minimum of 1 month
    (4 weeks) after dosing has been completed.
    E.4Principal exclusion criteria
    - Previous treatment with any other TKI, except imatinib
    - Current Grade 3 or 4 imatinib-related adverse event
    - Subjects with clonal evolution in Ph+ cells observed in ≥ 2 metaphases at baseline
    bone marrow (BM) cytogenetic test, unless the same abnormalities were present
    at diagnosis (See Section 5.8.2 for subjects exempt from baseline bone marrow
    cytogenetic assessment)
    - Subjects with previous loss of CHR or loss of major cytogenetic response
    (MCyR) on imatinib
    - Previous diagnosis of accelerated or blast phase CML
    - A serious uncontrolled medical disorder or active infection that would impair the
    ability of the subject to receive protocol therapy
    - Uncontrolled or significant cardiovascular disease, including any of the following:
    i. Congestive cardiac failure (NYHA > 2) within 3 months
    ii. Diagnosed or suspected congenital long QT syndrome
    iii. Any history of clinically significant ventricular arrhythmias
    iv. Prolonged QTcF interval on pre-entry electrocardiogram (> 450 msec)
    v. Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
    vi. Uncontrolled angina within 3 months
    vii. Prior myocardial infarction within 6 months
    viii. Uncontrolled hypertension
    - Known pulmonary arterial hypertension
    - Pleural or pericardial effusions of any grade at study entry are excluded. Subjects
    previously diagnosed with pleural/pericardial effusion of any grade resolved at the
    time of study entry are allowed
    - History of significant bleeding disorder unrelated to CML, including
    i. Diagnosed congenital bleeding disorders (eg, von Willebrand’s disease)
    ii. Diagnosed acquired bleeding disorder within one year (eg, acquired antifactor
    VIII antibodies)
    - Serious mental illness interfering with the ability to participate in the study
    - Prior documented T315I mutation (Enrollment is not dependent upon results of
    baseline mutation analysis)
    - Patients who are pregnant or breastfeeding or likely to become pregnant
    - Men whose partner is unwilling or unable to avoid pregnancy
    - Prisoners or subjects who are involuntarily incarcerated
    - Subjects who are compulsorily detained for treatment of either a psychiatric or
    physical (eg, infectious disease) illness.
    - Subjects unable to complete patient-reported outcomes without assistance
    E.5 End points
    E.5.1Primary end point(s)
    To assess the rate of MMR after the switch to dasatinib
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 and 12 months after the switch to dasatinib
    E.5.2Secondary end point(s)
    To assess the rate of MR after the switch to dasatinib
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 and 12 months after the switch to dasatinib
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Korea, Republic of
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 75
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    At the end of the study, BMS will not continue to supply study drug to subjects or
    investigators unless BMS chooses to extend the study. The investigator should ensure
    that the subject receives appropriate standard of care to treat CML after study completion
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-01
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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